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§ ASIA-PACIFIC
MFDS
Ministry of Food and Drug Safety (South Korea)
South Korea
MFDS regulates medical devices in South Korea using a four-class system. The Korean Good Manufacturing Practice (KGMP) standard is required for all manufacturers. South Korea is an MDSAP participating country and has mutual recognition agreements with several regulatory authorities.
DEVICE CLASSES
Class I, II, III, IV
APPROVAL PATHWAY
MFDS registration
KEY REGULATORY FUNCTIONS
- ▸KGMP compliance
- ▸Technical documentation review
- ▸MDSAP participation
- ▸Clinical trial approval
- ▸Device registration
OFFICIAL WEBSITE
https://www.mfds.go.kr →MedFlux monitors MFDS regulatory changes, safety alerts, and market signals in real time — so your team never misses a critical update.
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